• Phase 1 trial will eval­u­ate Actimab-M in treating patients with multiple myeloma who are unresponsive to cur­rently avail­able ther­a­pies
• Clinical trial ini­ti­ated at Texas Oncology - Baylor Charles A. Sammons Cancer Center in Dallas, TX to be conducted by Principal Investigator and Trial Sponsor, Dr. Yair Levy
• Clinical pipe­line now in­cludes Iomab-B pivotal Phase 3 trial, Actimab-A Phase 2 trial and Actimab-M  Phase 1 trial

New York, NY (Press Release) -- Actinium Pharma­ceu­ticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive targeted ther­a­pies for cancers lacking effective treat­ment options, announced today that a Phase 1 clin­i­cal trial studying Actimab-M in multiple myeloma has been ini­ti­ated. Actimab-M is com­prised of the CD-33 targeting mono­clonal anti­body HuM-195 coupled to the alpha-particle emitter actinium 225. CD33 is an an­ti­gen found on hematopoietic cells in cer­tain blood cancers. It is commonly asso­ci­ated with myeloid malig­nan­cies in­­clud­ing AML, but recent re­search has shown that CD33 can also be found on malignant cells of approx­i­mately 25%-35% of all multiple myeloma patients. Furthermore, the ex­pres­sion of this marker in­­creases in re­lapsed and refractory myeloma.  In addi­tion, it predicts for a very aggressive course of disease. This makes CD33 a poten­tial target for the treat­ment of this usually fatal disease. Although treatable, multiple myeloma is cur­rently not con­sidered curable and almost all patients eventually relapse or become refractory to avail­able treat­ments as their con­di­tion progresses. In this new trial, Actimab-M will be used in patients who have progressing disease after 3 prior multiple myeloma treat­ment regi­mens or are refractory to QUAD (Caflizomib, Lenalidomide, Poma­lido­mide, Dexamethason).

“I am very excited to lead in the devel­op­ment of this novel and promising ap­proach,” said Dr. M. Yair Levy of Texas Oncology - Baylor Charles A. Sammons Cancer Center.  “Relapsed and refractory multiple myeloma is an area of high unmet medical need that we hope to address with Actimab-M. Myeloma is a very radio­sensi­tive cancer, and does not present with the neu­tro­penia and thrombo­cytopenia of AML. I would ex­pec­t toler­ability of this treat­ment to be better in this disease. Based on my pre­vi­ous ex­peri­ence with Actimab-A in AML and my research in the area of multiple myeloma, I believe that this targeted treat­ment could prove efficacious and be a part of our growing armamentarium against this disease.”

Sandesh Seth, Executive Chairman of Actinium Pharma­ceu­ticals said, “We are incredibly excited to see the initiation of this trial for Actimab-M in multiple myeloma. Not only does this mark the beginning of the ex­pansion of our clin­i­cal pipe­line beyond AML, it also dem­onstrates the broad applicability of our radio­immuno­therapy tech­nolo­gies that we intend to progress into new indi­ca­tions and patient pop­u­la­tions. Further, this reinforces Actinium’s commitment to devel­op­ing ther­a­pies for patients with unmet needs. We look forward to providing updates as this trial progresses.”

About Multiple Myeloma

Multiple Myeloma is a blood cancer char­ac­ter­ized by malignant transformation of the type of white blood cells called plasmocytes. These cells accumulate in the bone marrow and eventually lead to serious bone and kidney damage. Multiple Myeloma is the second most commonly diag­nosed blood cancer after Non-Hodgkin Lymphoma with esti­mated about 30,000 new cases per year in the US.  Almost 100,000 people in the US cur­rently live with the disease. Average age at diag­nosis is 70, and only 2% of cases occur in people younger than 40 years. There is cur­rently no cure for Multiple Myeloma, although a number of drugs have been approved for treat­ment of the disease. However, most patients eventually stop responding to avail­able treat­ments, which results in a high unmet medical need for re­lapsed and refractory forms of the disease.

About Actimab-M

Actimab-M is com­prised of the anti-CD33 mono­clonal anti­body HuM-195 coupled to actinium 225, an alpha-particle emitting radioisotope, and is the same construct of Actinium’s Actimab-A, which is cur­rently being studied in a Phase 2 clin­i­cal trial in patients newly diag­nosed with acute myeloid leukemia (AML) who are over the age of 60.  Actimab-A is being studied in AML at frac­tion­ated doses of 2.0 μCi/Kg admin­istered via infusion on day 1 and day 7 as a single cycle while Actimab-M is being studied in multiple myeloma as a single infusion up to 1.0 μCi/Kg for up to 8 cycles not to exceed 4.0 μCi/Kg total per patient. The Phase 1 trial for Actimab-M is a multi­center, open label, dose-escalation study. Patients will be admin­istered a starting dose level of 0.5 μCi/Kg of Actimab-M via infusion on day 1 of each cycle for up to 8 cycles with each cycle lasting 42 days. If this dose level is deemed safe, a second dose level of 1.0 μCi/kg will be explored for up to 4 cycles also of 42 days per cycle. Total dose received per patient is not to exceed 4.0 μCi/kg. In the event of dose limiting toxicities (DLTs) at the 0.5 μCi/Kg dose level, a dose level of 0.25 μCi/Kg will be explored. The Phase 1 trial will esti­mate maximum tolerated dose (MTD), assess adverse events, measure response rates (objective response rate, com­plete response rate, stringent com­plete response rate, very good partial response rate and partial response rate) as well as pro­gres­sion free survival (PFS) and over­all survival (OS).

About Actinium Pharma­ceu­ticals, Inc.

Actinium Pharma­ceu­ticals, Inc. is a bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive targeted ther­a­pies for patients with cancers lacking effective treat­ment options. Actinium's pro­pri­e­tary plat­form utilizes mono­clonal anti­bodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead prod­uct can­di­date Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell trans­plant, commonly referred to as bone marrow trans­plant. A bone marrow trans­plant is often the only poten­tial cure for patients with blood-borne cancers but the current stand­ard preparation for a trans­plant requires chemo­ther­apy and/or total body irradiation that result in sig­nif­i­cant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow trans­plant, leading to in­­creased trans­plant success and survival rates. The Company is cur­rently conducting a single pivotal 150-patient, multi­center Phase 3 clin­i­cal study of Iomab-B in patients with re­lapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second prod­uct can­di­date, Actimab-A, is cur­rently in a multi­center open-label, 53-patient Phase 2 trial for patients newly diag­nosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treat­ment options and often cannot tolerate the toxicities of standard frontline ther­a­pies. In addi­tion, Actinium is devel­op­ing Actimab-M, which is being studied in patients with re­lapsed or refractory multiple myeloma in a Phase 1 clin­i­cal trial. Actinium is also utilizing its alpha-particle immuno­therapy (APIT) tech­nology plat­form to generate new drug can­di­dates based on anti­bodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharma­ceu­ticals is based in New York, NY. To learn more about Actinium Pharma­ceu­ticals, please visit www.actiniumpharma.com and to follow @ActiniumPharma on Twitter please visit, www.twitter.com/actiniumpharma.

Forward-Looking Statements for Actinium Pharma­ceu­ticals, Inc. 

This news release con­tains "forward-looking state­ments" as defined in the Private Securities Litigation Reform Act of 1995. These state­ments are based on man­agement's current ex­pec­ta­tions and involve risks and un­cer­tain­ties, which may cause actual results to differ materially from those set forth in the state­ments. The forward-looking state­ments may in­clude state­ments regarding prod­uct devel­op­ment, prod­uct poten­tial, or financial per­for­mance. No forward-looking state­ment can be guar­an­teed and actual results may differ materially from those pro­jected. Actinium Pharma­ceu­ticals under­takes no obli­ga­tion to publicly update any forward-looking state­ment, whether as a result of new in­­for­ma­tion, future events, or other­wise.

Source: Actinium Pharma­ceu­ticals.